FDA has approved Philips’ digital pathology solution as a primary diagnosis tool – it’s about time

May 8th, 2017

Merdol Ibrahim

Following the FDA’s decision to approve Philips’ digital pathology solution, Merdol Ibrahim, Managing Director, Diaceutics, assesses the implications for laboratories and suggests this move heralds not the end of the pathologist’s microscope, but the beginning of patients receiving even better and faster diagnoses.

The news that the FDA has approved the Philips IntelliSite Pathology Solution (PIPS) is very positive and significant. It’s also likely to be the first of several more such approvals. The surprise is that Philips isn’t necessarily a big anatomic pathology player – the likes of Leica and Ventana have good presence with digital imaging platforms – but they have yet to seek FDA approval for primary diagnosis using digital technology. It may be that Philips has the edge on the competition with their electronic, optics and lab IT systems, which lend themselves to primary diagnosis, but more importantly Philips has provided robust evidence by submitting approximately 16,000 data reads from 2000 pathology cases. Companies such as Ventana, Leica (which acquired Aperio) and 3DHistech have mainly focussed on ‘interpretation’ of digitally scanned patient pathology slides. Many of the ‘digital interpretation’ immunohistochemistry algorithms have yet to find a place in routine pathology. In contrast, fluorescence in situ hybridisation (FISH) systems such as Bioview, along with Abbott Molecular FISH probes, have shown there can be a time-saving element to digital interpretation.

Philips’ primary focus on passing the FDA’s approval process heralds not the end of the pathologist’s microscope, but the beginning of patients receiving even better and faster diagnoses. Digitisation of patient samples allows for access of a patient’s case remotely, and by an expert pathologist based anywhere in the world. Furthermore, the advent of multiple biomarker tests per patient, and the need for specialised interpretation, opens up digital pathology even further. Philips does, however, have bigger plans than straightforward digital diagnosis, and in 2016 they teamed up with Visiopharm to include breast cancer panel algorithms. In the same year Philips also acquired Queens University Belfast spin-off, PathXL, which has an established tumor annotation algorithm.

Outside the US, the CE-marked system for in vitro diagnostics (IVDs) has been operational since 2014, but there doesn’t appear to have been the expected big uptake. This could be due to multiple reasons including cost reimbursement, scanning time, a need for more staff (most labs are already short staffed) and, more importantly, the cost to implement a digital platform and service. On a practical level, most pathologists are in the same building as the slide samples, so if the slides can simply be handed over, there’s no direct benefit from digitising patient samples. One advantage would be in digitising slides which have been sent into reference laboratories from external or remote labs.

It is a big decision to opt for digital pathology and it requires major investment by pathology labs. Even though there is an option to work and diagnose remotely, all laboratory stakeholders will have to invest in hardware such as high resolution calibrated monitors and viewing software. There could also be a licence cost for every ‘satellite lab’ that uses the system. Europe may be slow to take on the initial infrastructure due to the reasons described above, but digital pathology could be a business opportunity for any big labs offering a digital scanning service.

Unfortunately, labs could potentially end up storing ‘glass slides’ even after they are digitised, which will increase lab costs, as most countries will still have in place requirements that original patient samples/slides are stored for at least 10 years. There is, therefore, another costly hurdle to cross in changing procedures for discarding patient slides after they have been scanned.

This is a brilliant achievement for Philips and other digital pathology providers are sure to follow suit. The USA will definitely steam ahead with digital pathology as the patient workloads are much larger and they have a patient reimbursement system which is not readily available elsewhere in the world.

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